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Please note that RED mainly indicates additional info, GREEN changes, and BLUE deleted items
4.4. Special warnings and precautions for use
The occurrence of respiratory failure (potentially fatal), asystole/cardiac arrest (potentially fatal), angina, severe bradycardia or severe hypotension should also lead to treatment discontinuation.
Adenosine may precipitate or aggravate bronchospasm (see sections 4.3 and 4.8).
4.8. Undesirable effects
Cardiac Disorders: (previously Cardiovascular system)
- common: Hypotension (see section 4.4), AV block, ST segment depression, sustained or non-sustained ventricular tachycardia. (arrhythmias deleted)
- rare: bradycardia sometimes severe (see section 4.4)
- not known: asystole /Cardiac arrest (some cases with fatal outcome, see section 4.4): sinus tachycardia, atrial fibrillation, ventricular fibrillation
Respiratory, thoracic and mediastinal disorders: (previously Respiratory system)
- very common: dyspnea (or the urge to breathe deeply)
- rare: bronchospasm (see section 4.4), nasal congestion
- very rare: respiratory failure (see section 4.4) (apnoea moved)
- not known: apnea/respiratory arrest
Cases with fatal outcome of respiratory failure, of bronchospasm, and of apnea / respiratory arrest have been reported (deleted: usually in patients with evidence of pre-existing asthma / COPD)
Nervous system disorders: (previously Central nervous system)
- very common: headache
- common: dizziness, light-headedness (previously ‘or feeling light-headed)
- uncommon: paraesthesia,
- rare: tremor, drowsiness (previously tremors and drowsiness was listed under pshychiatric sidorders)
- not known: loss of consciousness / syncope, convulsions, especially in predisposed patients (see section 4.4)
Eye disorders:
- rare: blurred vision (previously listed under Special senses – that no longer exists)
Ear and labyrinth disorders:
- rare: tinnitus (previously listed under Special senses)
Psychiatric disorders:
- uncommon: nervousness
Gastro-intestinal disorders: (previously gastro-intestinal system disorders)
- common: nausea, vomiting, abdominal discomfort
- uncommon: metallic taste, dry mouth (previously listed under Special senses)
Renal and Urinary disorders: (previously Genital / Urinary system)
- rare: urinary urgency
Reproductive system and breast disorders:
- rare: nipple discomfort (previously listed under Genital / Urinary system)
Vascular disorders:
- very common: flushing
General disorders and administration site conditions:
- very common: chest pain or pressure (previously listed under ‘Body as a whole’ – that no longer exists)
- common: throat, neck and jaw discomfort (previously listed under ‘Body as a whole’ and abdominal deleted)
- uncommon: sweating, discomfort in the leg, arm or back, weakness (previously listed under ‘Body as a whole’)
- very rare: injection site reactions (previously listed under Application site disorders’ – that no longer exists)
5.1. Pharmacodynamic properties
ATC Code: Other Cardiac Preparations C01EB 10
Endogenous nucleoside with peripheral vasodilator / antiarrhythmic effect
10. DATE OF REVISION OF THE TEXT
May 2008
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